MAUDE Adverse Event Report: STAAR SURGICAL COMPANY AG ICL (IMPLANTABLE COLLAMER LENS); PHAKIC INTRAOCULAR LENS

Model Number TICM120V4

Device Problems Device Dislodged or Dislocated (2923); Positioning Problem (3009); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the (b)(4).But not marketed in the u.S.Diopter: -11.00/+06.00/x058.Device evaluated by manufacturer: no, device remains implanted.(b)(4).Conclusions: based on the complaint information, a specific root cause of the event could not be determined.(b)(4).

Event Description

The reporter stated the surgeon implanted a 12.0mm ticm120v4 -11.00/+06.00/x058 diopter implantable collamer lens in the patient's left eye on (b)(6) 2008.There was a lens rotation and lens repositioning.The patient experienced a second lens rotation not associated to a low vault.Lens remains implanted.Planning to exchange lens.Last visit on (b)(6) 2016, ucva was 20/300.See mfr.#2023826-2016-00450 for right eye.

Manufacturer Narrative

Patient's post-op best corrected visual acuity (bcva) was 20/20.Conclusion: patient had cataract in the operative eye or nontraumatic cataract in the fellow eye, the lens was not implanted in accordance with the dfu requirements.(b)(4).

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY AG; hauptstrasse 104; ch-2560, nidau ; SZ
• Manufacturer (Section G): STAAR SURGICAL COMPANY AG; hauptstrasse 104; ch-2560, nidau ; SZ
• Manufacturer Contact: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5583325
• MDR Text Key: 42849072
• Report Number: 2023826-2016-00451
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2011
• Device Model Number: TICM120V4
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 04/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 28 YR